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2009 Supreme(Pat) 170

PATNA HIGH COURT
Navaniti Prasad Singh, J.
Ranbaxy Laboratories Limited
Versus
Union Of India Through The Ministry Of Health & Family Welfare, Nirman Bhawan, New Delhi
Civil Writ Jurisdiction Case No. 2425 of 2006 6605 of 2006 4065 of 2006 5076 of 2006 6314 of 2006
Decided On : FEBRUARY 04, 2009

Headnote:Drugs and Cosmetics Act, 1940-Section 5 r/w Section 3 of Prevention of Food Adulteration Act, 1954-Food Safety and Standards Act, 2006-lssue as to whether products as manufactured, stored and marketed by petitioners, are Drugs within meaning of Drugs Act, 1940 or they are food within meaning of Food Adulteration Act, 1954-High Court nominated Director General of Health Services, Govt. of India to resolve the dispute-No procedural infirmity can be attributed to deliberations as held by Director General of Health Services and objection of State Drug Controller cannot be sustained-Merely because effect of a commodity being food is that it goes out of price control mechanism or attracts lesser excise duties, is no consideration-It is not drug as held by Director General of Health Services.

       Estoppel- There is no estoppel against law-Petitioners may have bona fide acted on a wrong advice and having become wiser, law permitting, changed their stand-Question of estoppel does not arise because it is a question of law and position of law.

       

JUDGEMENT

1. The five writ petitions raise a common question and, as such, have been taken up for final disposal at this stage itself with consent of parties.

2. The question raised is whether the products, as manufactured, stored and marketed by them, are drugs within the meaning of Drugs and Cosmetics Act, 1940, (hereinafter "Drugs Act") thus, requiring statutory compliance of the said Act and the Rules framed thereunder or they are food within the meaning of the Prevention of Food Adulteration Act, 1954 (hereinafter referred to as "Food Act") or they fall under both the Acts. The proceedings emanated from, so far as the first writ application is concerned (Ranbaxy Laboratories Limited), an inspection report dated 30.11.2005 conducted at their godown at Bahadurpur, Kankarbagh Road, Patna wherein the petitioner was directed not to sell some products without licences under the Drugs Act. During pendency of the writ petitions, the Parliament enacted on 23rd August, 2006 the Food Safety and Standards Act, 2006 (Central Act 34 of 2006), thus, the provisions and the applicability of this Act also became a matter to be considered.

3. In various writ applications, different commodities are in question which will be indicated later at an appropriate stage. The Bihar State Drug Controller, in substance, was of the view that notwithstanding these commodities having been accepted as "food" within the meaning of Prevention of Food Adulteration Act, in other States where they were manufactured were "drugs" covered by the Drugs Act and could not be marketed withogt statutory compliance under the Drugs Act and the Rules framed thereunder. Effectively, the storage for same and marketing of those commodities without drug licence came to be prohibited in this State. When this matter came up before this Court, this Court, on 28.4.2008, inter alia, recorded:

"The core issues in all these writ applications are whether the articles manufactured and sold by various petitioners, are Drugs covered under the provisions of the Drugs and Cosmetics Act, 1940 or food covered by the Prevention of Food Adulteration Act. The question is of some importance as the authorities in most of the cases outside the State of Bihar have held those articles to be food articles covered by Prevention of Food Adulteration Act whereas the Respondent-Bihar State Drug Controller has held them to be drug as contemplated under the Drugs and Cosmetics Act, 1940.

In my view, the question whether it is a drug as defined by Section 3 of the Drugs and Cosmetics Act or is an item of food or it is covered by both is a matter which should first receive the attention of a technical person who is competent to decide this question at the first instance.

Mr. Rajiv Nayyar learned senior counsel appearing in the case of Ranbaxy Laboratories Pvt. Ltd. submits that the articles sold by his company Ranbaxy Laboratories Pvt. Ltd. are food articles and duly licensed by authority under the PFA Act. The State Drug Controller has erroneously assumed jurisdiction in the matter. Referring to various clarifications and recommendations in their favour and other document that the article is not drug and pointed out that in terms of Section 5 of the Drugs and Cosmetics Act, 1940, a statutory body is there which is chaired by the Director General of Health Services, Government of India, ex-officio. He points out that under the provisions of the PFA Act there is a Central Committee in terms of Section 3 thereof in which again the Director General, Health Services, Government of India is the Chairman ex-officio. To my mind, this brings about an easy solution wherein the same expert chairs both the committees under both the Acts. Recently there has been a third Act i.e. Food Safety and Standards Act 2006. In the opinion of this Court it is better if first Director General, Health Services, Government of India as noted above who is the ex-officio Chairman of both the expert committees should decide whether the






























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